The Creighton Model (CrM) FertilityCare System is a natural family planning method that teaches couples to recognize and chart the signs of fertility and infertility in the woman's cycle and to use that knowledge to either achieve or avoid a pregnancy. The method is natural, safe and effective, and it helps the couple understand their fertility. Trained practitioners at FertilityCare Centers teach the Creighton Model across the country, internationally and long distance.

Several FertilityCare Centers and the University of Utah are conducting a study to evaluate the effectiveness of the Creighton Model (CrM) for new and return users wanting to avoid pregnancy. While past studies have shown that the Creighton Model is a highly effective method, this study will use new ways to measure how well it works. This is important because the knowledge gained will improve comparisons between the Creighton Model and other family planning methods. The study will also explore intentions and behaviors of couples to avoid or achieve a pregnancy.

The investigators hypothesize that for the CrM the pregnancy rate during perfect use to avoid pregnancy will be about 1% and the behaviorally determined avoiding-related pregnancy rate for the CrM will be about 6%. The investigators will also evaluate the pregnancy rate during "typical use" without a previously stated intention to conceive (in CrM terms, a mixture of avoiding and achieving-related behavior).

Pregnancy rates during perfect and typical use of the Creighton Model FertilityCare System (CrM) to avoid pregnancy in a way directly comparable to the approach used in recent family planning effectiveness studies [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The intention status of all pregnancies according to standard measures of intended, mistimed and unwanted pregnancy while recognizing the significant limitations of these measures [ Time Frame: 1 year ] [ Designated as safety issue: No ]

New and return users of the Creighton Model FertilityCare System, a method of Natural Family Planning.

Behavioral: Creighton Model System of Natural Family Planning

Participants will learn the Creighton Model, a standardized method of natural family planning, from FertilityCare Practitioners from established FertilityCare Centers. The learning can be done in-person or long distance.

Other Names:

Natural Family Planning

Ovulation Method

Fertility Awareness

Detailed Description:

There are a variety of natural family planning (NFP) methods available today that differ in algorithm and biomarkers used to identify women's fertile window. This study will directly evaluate the NFP system known as the Creighton Model FertilityCare System (CrM). The Creighton Model System is a well-established educational system about fertility which involves no devices. The CrM teaches women a standardized way of observing and describing their vaginal discharge each day during routine use of the bathroom, and interpreting the changes in vaginal discharge to determine whether they are likely to be fertile that day or not. Vaginal discharge changes as tracked by the CrM are an accurate indicator of the changes in secretions from the uterine cervix that relate to the approach of ovulation.

This study will also examine the relationship between a couple's stated intentions to achieve or avoid a pregnancy during each menstrual cycle with their sexual behavior during the same cycle. There is growing consensus among researchers that current measures of pregnancy intention are simplistic at best, and at worst can be very misleading. One of the purposes of the study is to explore the multiple dimensions of pregnancy motivations, intentions, and behaviors by newer detailed measures.

This study will enroll couples who are new or returning CrM users and who are trying to avoid a pregnancy at the time they begin use of the CrM. The participants will be recruited from CrM FertilityCare Centers. The design is a prospective cohort study, which is the optimal study design to assess different measures of effectiveness and intendedness simultaneously in a group of NFP users. Several of the key measures of intention and behavior required for this study must be assessed prior to the outcome of actual use of CrM over time and the outcome of pregnancy, to avoid recall bias. Outcomes for this study require relatively precise assessment of the timing of both intentions and behaviors, which is simply unavailable from recall. We plan to enroll at least 300 and up to 400 couples in the study. This represents 60% (300/497) of the estimated available and eligible couples learning the CrM for use to avoid pregnancy in one year at the participating FertilityCare Centers.

Eligibility

Ages Eligible for Study:

18 Years to 40 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

This study will enroll couples who are new or return Creighton Model (CrM) users and who are trying to avoid a pregnancy at the time they begin use of the CrM. The participants will be recruited from several CrM FertilityCare Centers across the United States and Canada. Participants who do not live near a center will be offered long distance teaching.

Criteria

Inclusion Criteria:

Being a new or return user of the Creighton Model with the stated intention of avoiding pregnancy

Sexually active or planning to be sexually active within 6 months of the enrollment date (relevant to some engaged couples who learn CrM)

The woman is between the ages of 18 to 40

The man is age 18 or older

The woman has had at least 2 menstrual flows in the past 3 months or at least one menstrual flow since stopping hormonal birth control

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012596

Locations

United States, California

Sacramento Diocese FertilityCare Services

Sacramento, California, United States, 95825

United States, Minnesota

Northland Family Programs: A FertilityCare Center

Duluth, Minnesota, United States, 55102

Twin Cities FertilityCare Center

St. Paul, Minnesota, United States, 55102

United States, Missouri

FertilityCare Center of Kansas City

Blue Springs, Missouri, United States, 64014

St. John's Mercy Medical Center, Department of FertilityCare Services

St. Louis, Missouri, United States, 63141

United States, Nebraska

FertilityCare Center, Diocese of Lincoln

Lincoln, Nebraska, United States, 68501

FertilityCare Center of Omaha

Omaha, Nebraska, United States, 68106

United States, New Hampshire

FertilityCare Services St. Joseph Hospital

Nashua, New Hampshire, United States, 03060

United States, New Mexico

St. Joseph FertilityCare Center

Albuquerque, New Mexico, United States, 87120

United States, Ohio

Caritas FertilityCare Center

Pataskala, Ohio, United States, 43062

United States, Pennsylvania

Center for Women's Health, Spirit FertilityCare Services

Camp Hill, Pennsylvania, United States, 17011

United States, South Carolina

FertilityCare Services: Diocese of Charleston, SC

Greer, South Carolina, United States, 29650

United States, Texas

FertilityCare Center of North Texas

Ft. Worth, Texas, United States, 76137

Women's FertilityCare Services of Houston

Houston, Texas, United States, 88018

United States, Utah

If you don't find a center near you, contact us for Long Distance Learning